Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-20 @ 7:24 PM
Study NCT ID:
NCT02038660
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Eluting Balloon Registry in Routine Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000800', 'term': 'Angioplasty, Balloon'}], 'ancestors': [{'id': 'D017130', 'term': 'Angioplasty'}, {'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Event', 'timeFrame': '1year', 'description': 'Death, Non-fatal myocardial infarction, Target vessel revascularization'}], 'secondaryOutcomes': [{'measure': 'All cause death', 'timeFrame': '5year'}, {'measure': 'Cardiac death', 'timeFrame': '5year'}, {'measure': 'Myocardial infarction', 'timeFrame': '5year'}, {'measure': 'Composite event', 'timeFrame': '5year', 'description': 'Death or myocardial infarction'}, {'measure': 'Composite event', 'timeFrame': '5year', 'description': 'Cardiac death or myocardial infarction'}, {'measure': 'Target vessel revascularization', 'timeFrame': '5year'}, {'measure': 'Target lesion revascularization', 'timeFrame': '5year'}, {'measure': 'Stent thrombosis', 'timeFrame': '5year', 'description': 'Classification of stent thrombosis according to Academic Research Consortium criteria'}, {'measure': 'Stroke', 'timeFrame': '5year'}, {'measure': 'Procedural Success', 'timeFrame': '3day', 'description': 'Defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization.\n\nParticipants will be followed for the duration of hospital stay, an expected average of 3days.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Angioplasty, Balloon'], 'conditions': ['Coronary Artery Disease', 'Angioplasty, Balloon']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with balloon angioplasty', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow\n* Age 20 and more\n* Treated with Balloon angioplasty\n* Signed informed consent and agreed to follow protocol\n\nExclusion Criteria:\n\n* Allergy to paclitaxel, antiplatelet\n* History of side effect to heparin, aspirin, thienopyridines\n* History of bleeding tendency, coagulation disorder, blood transfusion reaction'}, 'identificationModule': {'nctId': 'NCT02038660', 'acronym': 'IRIS DEB', 'briefTitle': 'Drug-Eluting Balloon Registry in Routine Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'AMCCV2013-10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with coronary artery disease', 'interventionNames': ['Device: Balloon angioplasty']}], 'interventions': [{'name': 'Balloon angioplasty', 'type': 'DEVICE', 'armGroupLabels': ['Patients with coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'CHANG-WOOK NAM, MD', 'role': 'CONTACT', 'email': 'cvcrc10@amc.seoul.kr'}, {'name': 'CHANG-WOOK NAM, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Daejeon ST. Mary's Hospital", 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Pusan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'MOO-HYUN KIM, MD', 'role': 'CONTACT', 'email': 'cvcrc10@amc.seoul.kr'}, {'name': 'MOO-HYUN KIM, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dong-A Medical Center', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SEUNG-JUNG PARK, MD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr'}, {'name': 'SEUNG-JUNG PARK, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyuck-moon Kwon, MD', 'role': 'CONTACT', 'email': 'cvcrc10@amc.seoul.kr'}, {'name': 'Hyuck-moon Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-woon Rha, MD', 'role': 'CONTACT', 'email': 'cvcrc10@amc.seoul.kr'}, {'name': 'Seung-woon Rha, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'status': 'TERMINATED', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is not a publicly funded trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}, {'name': 'B. Braun Korea Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}